FDA.reportPublic FDA data

ABBOTT MEDICAL

Matched from indexed company URL: Abbott Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20178652017865ABBOTT MEDICAL1N2027-01-0115900 Valley View Court Sylmar CA US 91342
30049361103004936110Abbott Medical1N2027-01-01387 Nerem St Nw Ste 500 Atlanta GA US 30313
30067058153006705815Abbott Medical1Y2027-01-01LOT A INTERIOR - No. 2 RD KM 67.5 SANTANA INDUSTRIAL PARK Arecibo PR US 00612
30084943153008377825Abbott Medical1N2027-01-01Plot 102, Lebuhraya Kampung Jawa Bayan Lepas Industrial Zone Penang Pulau Pinang MY 11900
30117067993011706799Abbott Medical1N2027-01-011850 MacArthur Blvd NW Suite B Atlanta GA US 30318
30132882013013288201ABBOTT MEDICAL1N2027-01-0114901 Deveau Pl. Building 2 Minnetonka MN US 55345
16274871627487Abbott Medical1N2026-01-016901 Preston Rd PLANO TX US 75024
21351473005334138Abbott Medical1N2026-01-015050 NATHAN LANE NORTH Plymouth MN US 55442
26486122648612Abbott Medical1N2026-01-01LOT 20 B Street Caguas West Industrial Park Caguas PR US 00725
30071134873007113487Abbott Medical1N2026-01-01177 County Road B East Saint Paul MN US 55117
30096000983009600098Abbott Medical1N2026-01-014 Robbins Rd Westford MA US 01886
30209508183020950818Abbott Medical1N2026-01-011820 Bastian Court Westfield IN US 46074
30100686583010068658Abbott Medical1N2020-04-25177 County Road B East Saint Paul MN US 55117

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2049411864801312P970030TORONTO SPV VALVELWR1997-11-04
2008181609226794P970013MICRONY PACEMAKERSLWO2000-12-21
59311609226794P970013MICRONY PACEMAKERSLWO2000-12-21
3298501609226794P970013MICRONY PACEMAKERSLWO2000-12-21
819501949371366P960030PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADSNVN1998-01-29
59311949371366P960030PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADSNVN1998-01-29
2008181949371366P960030PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADSNVN1998-01-29
3298501949371366P960030PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADSNVN1998-01-29
59311615224818P960013TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSNVN1997-06-20
819501615224818P960013TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSNVN1997-06-20
2008181615224818P960013TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSNVN1997-06-20
3298501615224818P960013TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSNVN1997-06-20
59311405123025P950022TVL(TM) LEAD SYSTEMLWS1996-05-10
2008181405123025P950022TVL(TM) LEAD SYSTEMLWS1996-05-10
819501405123025P950022TVL(TM) LEAD SYSTEMLWS1996-05-10
3298501405123025P950022TVL(TM) LEAD SYSTEMLWS1996-05-10
59311461275087P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEMLWS1993-04-30
819501461275087P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEMLWS1993-04-30
2008181461275087P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEMLWS1993-04-30
819501346726378P880086ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSDXY1989-08-21
59311346726378P880086ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSDXY1989-08-21
2008181346726378P880086ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSDXY1989-08-21
3298501346726378P880086ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSDXY1989-08-21
819501089540043P880006SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMMDXY1989-02-28
59311089540043P880006SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMMDXY1989-02-28
59271427691137P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ1982-12-17
952821427691137P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ1982-12-17
2049411427691137P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ1982-12-17
952821072781342P240042Tendyne Transcatheter Mitral Valve SystemNPU2025-05-23
2049411072781342P240042Tendyne Transcatheter Mitral Valve SystemNPU2025-05-23
2049411118222661P230007TriClip G4 SystemNPS2024-04-01
952821118222661P230007TriClip G4 SystemNPS2024-04-01
2049411772560416P200049Amplatzer™ Amulet™ Left Atrial Appendage OccluderNGV2021-08-14
952821772560416P200049Amplatzer™ Amulet™ Left Atrial Appendage OccluderNGV2021-08-14
952821317995609P190023Portico Transcatheter Aortic Valve Implantation SystemNPT2021-09-17
2049411317995609P190023Portico Transcatheter Aortic Valve Implantation SystemNPT2021-09-17
59311957404550P150035Aveir VR Leadless SystemPNJ2022-03-31
3298501957404550P150035Aveir VR Leadless SystemPNJ2022-03-31
819501957404550P150035Aveir VR Leadless SystemPNJ2022-03-31
59381478505081P150004Axium Neurostimulator SystemPMP2016-02-11
59312051987943P140033Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer SoftwareLWP2017-01-31
2008182051987943P140033Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer SoftwareLWP2017-01-31
819502051987943P140033Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer SoftwareLWP2017-01-31
3298502051987943P140033Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer SoftwareLWP2017-01-31
59381326517770P140009BRIO NEUROSTIMULATION SYSTEMMHY2015-06-12
2008181326517770P140009BRIO NEUROSTIMULATION SYSTEMMHY2015-06-12
819501326517770P140009BRIO NEUROSTIMULATION SYSTEMMHY2015-06-12
2049411148803325P120021AMPLATZER PFO OCCLUDERMLV2016-10-28
952821148803325P120021AMPLATZER PFO OCCLUDERMLV2016-10-28
2162811548003494P100045CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEMMOM2014-05-28
3099501548003494P100045CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEMMOM2014-05-28
952821259362317P100029ST JUDE MEDICAL TRIFECTA VALVELWR2011-04-20
2049411259362317P100029ST JUDE MEDICAL TRIFECTA VALVELWR2011-04-20
3016761128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
952821128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
2049411128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
2049411948089994P040040AMPLATZER MUSCULAR VSD OCCLUDERMLV2007-09-07
952821948089994P040040AMPLATZER MUSCULAR VSD OCCLUDERMLV2007-09-07
952821469465816P040021SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVELWR2005-08-05
2049411469465816P040021SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVELWR2005-08-05
59311599943823P030054ST JUDE MEDICAL EPIC HF SYSTEMNIK2004-06-30
819501599943823P030054ST JUDE MEDICAL EPIC HF SYSTEMNIK2004-06-30
2008181599943823P030054ST JUDE MEDICAL EPIC HF SYSTEMNIK2004-06-30
3298501599943823P030054ST JUDE MEDICAL EPIC HF SYSTEMNIK2004-06-30
59311539821199P030035ANTHEM AND FRONTIER II CRT-P'SNKE2004-05-13
819501539821199P030035ANTHEM AND FRONTIER II CRT-P'SNKE2004-05-13
2008181539821199P030035ANTHEM AND FRONTIER II CRT-P'SNKE2004-05-13
3298501539821199P030035ANTHEM AND FRONTIER II CRT-P'SNKE2004-05-13
2049411437057228P020024AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEMMAE2003-05-14
952821437057228P020024AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEMMAE2003-05-14
59381213468741P010032GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMSLGW2001-11-21
819501213468741P010032GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMSLGW2001-11-21
59311213468741P010032GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMSLGW2001-11-21
2049411720702331P000039THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEMMLV2001-12-05
952821720702331P000039THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEMMLV2001-12-05
59381772202268K992946RENEW RECEIVERGZB1999-09-24
59381135856364K990469LAMITRODE LEADSGZB1999-06-03
59382023801547K960728ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)GZB1996-05-22
819502023801547K960728ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)GZB1996-05-22
59311921274733K950140IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069DTD1995-04-06
59381780816653K941342PAIN DOCGZB1995-10-13
2049411426393649K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
952821426393649K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
59381971527699K930536NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM RECGZB1994-12-15
59381551150553K930498NEUROMED OCTRODE MODEL MNT-98 NEUROSTIMULATOR TRANGZB1994-12-12
59381821119545K930242INTRODE INT-8GZB1994-02-02
59311583375331K921318ADAPTING SLEEVE KIT MODEL 4023DTD1992-08-03
3298501071559481K914185PACEL(TM) FLOW DIRECTED PACING CATHETERLDF1992-01-27
3298501900612166K910645DISPOSABLE PATIENT CABLEDSA1991-05-07
59381427850039K903814NEUROMED TS8 TEST STIMULATORGZB1991-01-16
3298501708793242K875059DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODELDF1988-02-12
2049411961154169K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterDQY2026-07-02
952821961154169K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterDQY2026-07-02
2049411802099928K261631Amplatzer TorqVue Exchange SystemDQY2026-06-17
952821802099928K261631Amplatzer TorqVue Exchange SystemDQY2026-06-17
2049412051541396K260993Amplatzer TorqVue Delivery SystemDQY2026-04-24
952822051541396K260993Amplatzer TorqVue Delivery SystemDQY2026-04-24
2049411955780459K260499Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80DQY2026-03-13
952821955780459K260499Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80DQY2026-03-13
59311400711123K253516Assert-IQ (DM5100)MXD2025-12-18
2079951263121909K253459OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)NQQ2026-04-24
952821521462825K252417Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)DQY2025-12-17
2049411521462825K252417Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)DQY2025-12-17
59311925374185K251221Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)MXD2025-09-17
952821557844089K250426Amulet™ Steerable Delivery SheathDQY2025-04-25
2049411557844089K250426Amulet™ Steerable Delivery SheathDQY2025-04-25
952821514118340K250031Amplatzer GuidewireDQX2025-10-03
2049411514118340K250031Amplatzer GuidewireDQX2025-10-03
952821780190841K243224MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801)DQY2024-12-31
2049411780190841K243224MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801)DQY2024-12-31
3016761780190841K243224MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801)DQY2024-12-31
59381892153185K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)GXI2025-05-27
952821430420592K241538TriClip Steerable Guide CatheterDQY2024-08-26
2049411430420592K241538TriClip Steerable Guide CatheterDQY2024-08-26
952821165671949K232690Amulet™ Steerable Delivery SheathDQY2023-09-29
2049411165671949K232690Amulet™ Steerable Delivery SheathDQY2023-09-29
2079951362972053K232386ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6NQQ2023-09-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQY642026-07-02
GZB402014-05-02
MXC202023-05-17
KRH142009-10-16
NQQ122026-04-24
DQX112025-10-03
KRD82012-06-12
NVN81998-01-29
DYB72023-03-01
LWS71996-05-10
GXI62025-05-27
DRA62022-09-28
MLV62016-10-28
LGW52001-11-21
DQO42023-04-14
GXD42022-01-21
LWP42017-01-31
LDF42016-11-22
MHY42015-06-12
LWR42011-04-20
NIK42004-06-30
NKE42004-05-13
DXY41989-08-21
DQK32022-04-30
LWO 32022-03-31
NKM32013-10-24
DRB32009-04-01
LWO32000-12-21
LWQ31982-12-17
MXD22025-12-18
MMX22022-04-01
NPT 22021-09-17
NGV 22021-08-14
GXR22018-07-20
MOM22014-05-28
DXC22011-02-24
DSA22010-04-02
MJN22005-12-30
MAE22003-05-14
DTD21995-04-06

PMA#

200 records. Showing 1-40. Next

PMN#

41 records. Showing 1-40. Next